[Federal Register Volume 85, Number 31 (Friday, February 14, 2020)]
[Rules and Regulations]
[Pages 8441-8447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-02043]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2019-0129; FRL-10002-96]


Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate]; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement 
of a tolerance for residues of ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate] when used as an inert ingredient 
(stabilizer) limited to 1% (by weight) in pesticide formulations 
applied to growing crops, and raw agricultural commodities after 
harvest. Syngenta Crop Protection, LLC submitted a petition to EPA 
under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting 
establishment of an exemption from the requirement of a tolerance. This 
regulation eliminates the need to establish a maximum permissible level 
for residues of ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-
m-tolyl) propionate] when used in accordance with the terms of this 
exemption.

DATES: This regulation is effective February 14, 2020. Objections and 
requests for hearings must be received on or before April 14, 2020, and 
must be filed in accordance with the instructions provided in 40 CFR 
part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket 
identification (ID) number EPA-HQ-OPP-2019-0129, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory 
Public Docket (OPP Docket) in the Environmental Protection Agency 
Docket Center (EPA/DC), West William

[[Page 8442]]

Jefferson Clinton Bldg., Rm. 3334, 1301 Constitution Ave. NW, 
Washington, DC 20460-0001. The Public Reading Room is open from 8:30 
a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The 
telephone number for the Public Reading Room is (202) 566-1744, and the 
telephone number for the OPP Docket is (703) 305-5805. Please review 
the visitor instructions and additional information about the docket 
available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Michael L. Goodis, Registration 
Division (7505P), Office of Pesticide Programs, Environmental 
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460-
0001; main telephone number: (703) 305-7090; email address: 
RDFRNotices@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an 
agricultural producer, food manufacturer, or pesticide manufacturer. 
The following list of North American Industrial Classification System 
(NAICS) codes is not intended to be exhaustive, but rather provides a 
guide to help readers determine whether this document applies to them. 
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR 
part 180 through the Government Publishing Office's e-CFR site at 
http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an 
objection to any aspect of this regulation and may also request a 
hearing on those objections. You must file your objection or request a 
hearing on this regulation in accordance with the instructions provided 
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify 
docket ID number EPA-HQ-OPP-2019-0129 in the subject line on the first 
page of your submission. All objections and requests for a hearing must 
be in writing, and must be received by the Hearing Clerk on or before 
April 14, 2020. Addresses for mail and hand delivery of objections and 
hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the 
Hearing Clerk as described in 40 CFR part 178, please submit a copy of 
the filing (excluding any Confidential Business Information (CBI)) for 
inclusion in the public docket. Information not marked confidential 
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without 
prior notice. Submit the non-CBI copy of your objection or hearing 
request, identified by docket ID number EPA-HQ-OPP-2019-0129, by one of 
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the online instructions for submitting comments. Do not submit 
electronically any information you consider to be CBI or other 
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket 
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW, Washington, DC 
20460-0001.
     Hand Delivery: To make special arrangements for hand 
delivery or delivery of boxed information, please follow the 
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along 
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of June 7, 2019 (84 FR 26630) (FRL-9993-
93), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C. 
346a, announcing the filing of a pesticide petition (PP IN-11245) by 
Syngenta Crop Protection, LLC, 410 Swing Road, P.O. Box 18300, 
Greensboro, NC 27419-8300. The petition requested the establishment of 
an exemption from the requirement of a tolerance for residues of 
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate] (CAS Reg. No. 36443-68-2) when used as an inert ingredient 
(stabilizer) at no more than 1% by weight in pesticide formulations 
applied to or on raw agricultural commodities and growing crops under 
40 CFR 180.910. That document referenced a summary of the petition 
prepared by Syngenta Crop Protection, LLC, the petitioner, which is 
available in the docket at http://www.regulations.gov. There were no 
comments received in response to the notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active 
ingredients as defined in 40 CFR 153.125 and include, but are not 
limited to, the following types of ingredients (except when they have a 
pesticidal efficacy of their own): Solvents such as alcohols and 
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty 
acids; carriers such as clay and diatomaceous earth; thickeners such as 
carrageenan and modified cellulose; wetting, spreading, and dispersing 
agents; propellants in aerosol dispensers; microencapsulating agents; 
and emulsifiers. The term ``inert'' is not intended to imply 
nontoxicity; the ingredient may or may not be chemically active. 
Generally, EPA has exempted inert ingredients from the requirement of a 
tolerance based on the low toxicity of the individual inert 
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an 
exemption from the requirement for a tolerance (the legal limit for a 
pesticide chemical residue in or on a food) only if EPA determines that 
the tolerance is ``safe.'' Section 408(c)(2)(A)(ii) of FFDCA defines 
``safe'' to mean that ``there is a reasonable certainty that no harm 
will result from aggregate exposure to the pesticide chemical residue, 
including all anticipated dietary exposures and all other exposures for 
which there is reliable information.'' This includes exposure through 
drinking water and in residential settings, but does not include 
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to 
give special consideration to exposure of infants and children to the 
pesticide chemical residue in establishing a tolerance and to ``ensure 
that there is a reasonable certainty that no harm will result to 
infants and children from aggregate exposure to the pesticide chemical 
residue. . . .''
    EPA establishes exemptions from the requirement of a tolerance only 
in those cases where it can be clearly demonstrated that the risks from 
aggregate exposure to pesticide chemical residues under reasonably 
foreseeable circumstances will pose no appreciable risks to human 
health. In order to determine the risks from aggregate exposure to 
pesticide inert ingredients, the Agency considers the toxicity of the 
inert in conjunction with possible exposure to residues of the inert 
ingredient through food, drinking water, and through other exposures 
that

[[Page 8443]]

occur as a result of pesticide use in residential settings. If EPA is 
able to determine that a finite tolerance is not necessary to ensure 
that there is a reasonable certainty that no harm will result from 
aggregate exposure to the inert ingredient, an exemption from the 
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors 
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available 
scientific data and other relevant information in support of this 
action. EPA has sufficient data to assess the hazards of and to make a 
determination on aggregate exposure for ethylenebis(oxyethylene) bis[3-
(5-tert-butyl-4-hydroxy-m-tolyl) propionate] including exposure 
resulting from the exemption established by this action. EPA's 
assessment of exposures and risks associated with 
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate] follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their 
validity, completeness, and reliability as well as the relationship of 
the results of the studies to human risk. EPA has also considered 
available information concerning the variability of the sensitivities 
of major identifiable subgroups of consumers, including infants and 
children. Specific information on the studies received and the nature 
of the adverse effects caused by ethylenebis(oxyethylene) bi[3-(5-tert-
butyl-4-hydroxy-m-tolyl)propionate] as well as the no-observed-adverse-
effect-level (NOAEL) and the lowest-observed-adverse-effect-level 
(LOAEL) from the toxicity studies are discussed in this unit.
    Acute toxicity is low for ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate]. In rats, the lethal dose 
(LD50) for acute oral and dermal toxicity is greater than 
7,000 and 2,000 milligrams/kilogram/day (mg/kg/day), respectively. It 
is not a dermal or eye irritant, or a sensitizer.
    Subchronic exposure to ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate] in rats resulted in increased 
liver weights and alanine aminotransferase (ALAT) activity at 112 mg/
kg/day and minimal thyroid follicular hypertrophy at doses greater than 
250 mg/kg/day. The NOAELs were 37.4 and 50 mg/kg/day, respectively. In 
dogs, no toxicity is seen at doses up to 300 mg/kg/day, the highest 
dose tested.
    No fetal susceptibility was observed in the developmental studies. 
Maternal toxicity (reduced bodyweight gain and food consumption) occurs 
at 100 mg/kg/day while developmental toxicity (reduced bodyweight and 
delayed skeletal maturation) occurs at 300 mg/kg/day. The maternal 
NOAEL was not established, and the developmental NOAEL is 100 mg/kg/
day.
    Qualitative fetal susceptibility was observed in the 2-generation 
reproduction toxicity study. Pup mortality and reduced body weight were 
observed in offsprings at 900 parts per million (ppm) (~54 to 62 mg/kg/
day). In parents, decreased bodyweight gain and food consumption 
occurred at the same dose. However, the established chronic reference 
dose (cRfD) of 0.15 mg/kg/day will be protective of offspring effects. 
The parental and offspring NOAELs are 300 ppm (~21 to 26 mg/kg/day). 
Reproduction toxicity was not observed up to 1,800 ppm (~108 to 124 mg/
kg/day), the highest dose tested.
    The combined chronic/carcinogenicity study showed focal cystic 
dilatation of the liver sinusoids and thyroid follicle hyperplasia at 
doses greater than 50 mg/kg/day. The NOAEL is 15 mg/kg/day. There was a 
treatment-related increase in thyroid tumor incidence at 100 mg/kg/day 
in both sexes. However, it is well established that alterations in rat 
thyroid hormones can alter the thyroid gland resulting in tumor 
formation. Based on the mechanistic studies, the postulated mode of 
action is that ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-
m-tolyl) propionate] disrupts the rat thyroid-pituitary axis primarily 
through interference of peripheral T4 metabolism. The relevancy of 
thyroid tumors to man is limited, as rats are very sensitive to small 
changes in plasma T4 levels while humans are insensitive due to a 
number of physiological differences including the amount of thyroxin-
binding globulin present, half-life of T4 between different species, 
and difference in responsiveness to thyrotropin releasing hormone. 
Therefore, the thyroid gland tumors observed in this study are not 
considered relevant to humans.
    The Ames test, mammalian cell gene mutation and micronucleus assays 
were conducted with ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-
hydroxy-m-tolyl) propionate]. These studies were negative; therefore, 
it is not expected to be mutagenic.
    Neurotoxicity and immunotoxicity studies are not available for 
review. However, evidence of neurotoxicity and immunotoxicity is not 
observed in the submitted studies.
    In a metabolism study in rats, ethylenebis(oxyethylene) bis[3-(5-
tert-butyl-4-hydroxy-m-tolyl) propionate] administered orally is 
rapidly absorbed and metabolized. It is primarily excreted in the urine 
and feces. Metabolites were not identified in this study; however, it 
is a phenolic antioxidant and based on the classical metabolic pathway 
for this class of chemicals, it would be subject to glucuronide or 
sulphate conjugation, hydroxylation of the phenyl ring, and side chain 
oxidation. The resulting metabolites are expected to be 3-(3-tert-
butyl-4-hydroxy-5-methyl-phenyl)propanoic acid and 2-[2-(2-
hydroxyethoxy)ethoxy]ethanol (triethylene glycol).
    Dermal absorption rate was calculated to be 0.53% in a dermal 
absorption study in miniature pigs.

B. Toxicological Points of Departure/Levels of Concern

    Once a pesticide's toxicological profile is determined, EPA 
identifies toxicological points of departure (POD) and levels of 
concern to use in evaluating the risk posed by human exposure to the 
pesticide. For hazards that have a threshold below which there is no 
appreciable risk, the toxicological POD is used as the basis for 
derivation of reference values for risk assessment. PODs are developed 
based on a careful analysis of the doses in each toxicological study to 
determine the dose at which no adverse effects are observed (the NOAEL) 
and the lowest dose at which adverse effects of concern are identified 
(the LOAEL). Uncertainty/safety factors are used in conjunction with 
the POD to calculate a safe exposure level--generally referred to as a 
population-adjusted dose (PAD) or a reference dose (RfD)--and a safe 
margin of exposure (MOE). For non-threshold risks, the Agency assumes 
that any amount of exposure will lead to some degree of risk. Thus, the 
Agency estimates risk in terms of the probability of an occurrence of 
the adverse effect expected in a lifetime. For more information on the 
general principles EPA uses in risk characterization and a complete 
description of the risk assessment process, see http://www.epa.gov/pesticides/factsheets/riskassess.htm.
    The chronic/carcinogenicity toxicity study in rats was selected for 
all exposure scenarios. The NOAEL is 15 mg/kg/day, and the LOAEL is 50 
mg/kg/day based on focal cystic dilatation of the liver sinusoids and 
thyroid follicle hyperplasia. This represents the lowest NOAEL in the 
database in the most sensitive species. However, in the developmental 
study, the maternal

[[Page 8444]]

NOAEL is not established and the maternal LOAEL is 100 mg/kg/day based 
on decreased bodyweight gain and food consumption. Also, decreased 
bodyweight gain and food consumption are observed in parental animals 
at 900 ppm (~ 54 to 62 mg/kg/day) in the two-generation reproduction 
toxicity study, the NOAEL is 300 ppm (~ 21 to 26 mg/kg/day). Since, 
maternal and parental effects are the same in both studies, a parental 
NOAEL is established and treatment duration is longer in the two-
generation reproduction toxicity study, it is considered adequate to 
address the lack of a maternal NOAEL in the developmental study. The 
standard inter- and intra-species uncertainty factors of 10x are 
applied; as discussed below in Unit IV.D., the Agency applied a 1X Food 
Quality Protection Act Safety Factor (FQPA) SF. The dermal absorption 
factor of 0.53% is applied based on a dermal absorption study in 
miniature pigs. The default factor of 100% is applied for the 
inhalation absorption rate.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary 
exposure to ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-
tolyl) propionate], EPA considered exposure under the proposed 
exemption from the requirement of a tolerance. EPA assessed dietary 
exposures from ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-
m-tolyl) propionate] in food as follows:
    No adverse effects attributable to a single exposure of endpoint 
was identified for ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-
hydroxy-m-tolyl) propionate]; therefore, an acute dietary exposure 
assessment was not conducted.
    In conducting the chronic dietary exposure assessment using the 
Dietary Exposure Evaluation Model DEEM-FCIDTM, Version 3.16, EPA used 
food consumption information from the U.S. Department of Agriculture's 
(USDA's) 2003-2008 National Health and Nutrition Examination Survey, 
What We Eat in America (NHANES/WWEIA). As to residue levels in food, no 
residue data were submitted for ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate]. In the absence of specific 
residue data, EPA has developed an approach which uses surrogate 
information to derive upper bound exposure estimates for the subject 
inert ingredient. Upper bound exposure estimates are based on the 
highest tolerance for a given commodity from a list of high use 
insecticides, herbicides, and fungicides. A complete description of the 
general approach taken to assess inert ingredient risks in the absence 
of residue data is contained in the memorandum entitled ``Alkyl Amines 
Polyalkoxylates (Cluster 4): Acute and Chronic Aggregate (Food and 
Drinking Water) Dietary Exposure and Risk Assessments for the Inerts,'' 
(D361707, S. Piper, 2/25/09) and can be found at http://www.regulations.gov in docket ID number EPA-HQ-OPP-2008-0738.
    In the dietary exposure assessment, the Agency assumed that the 
residue level of the inert ingredient would be no higher than the 
highest tolerance for a given commodity. Implicit in this assumption is 
that there would be similar rates of degradation (if any) between the 
active and inert ingredient and that the concentration of inert 
ingredient in the scenarios leading to these highest levels of 
tolerances would be no higher than the concentration of the active 
ingredient.
    Although EPA is assessing ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate at 1.75% (to account for the 
requested 1% (by weight) limitation in pesticide formulations and up to 
0.75% limitation for the FDA approved uses as an antioxidant and/or 
stabilizer for polymers used for food contact applications, the Agency 
believes the assumptions used to estimate dietary exposures lead to an 
very conservative assessment of dietary risk due to other conservative 
assumptions.
    First, EPA assumes that, for each commodity, the active ingredient 
which will serve as a guide to the potential level of inert ingredient 
residues is the active ingredient with the highest tolerance level. 
This assumption overstates residue values because it would be highly 
unlikely, given the high number of inert ingredients, that a single 
inert ingredient or class of ingredients would be present at the level 
of the active ingredient in the highest tolerance for every commodity. 
Also, EPA's assumes that all foods contain the inert ingredient at the 
highest tolerance level. In other words, EPA assumed 100 percent of all 
foods are treated with the inert ingredient at the rate and manner 
necessary to produce the highest residue legally possible for an active 
ingredient. In summary, EPA chose a very conservative method for 
estimating what level of inert residue could be on food, then used this 
methodology to choose the highest possible residue that could be found 
on food and assumed that all food contained this residue. No 
consideration was given to potential degradation between harvest and 
consumption even though monitoring data shows that tolerance level 
residues are typically one to two orders of magnitude higher than 
actual residues in food when distributed in commerce.
    Accordingly, although sufficient information to quantify actual 
residue levels in food is not available, the compounding of these 
conservative assumptions will lead to a significant exaggeration of 
actual exposures. EPA does not believe that this approach 
underestimates exposure in the absence of residue data.
    2. Dietary exposure from drinking water. For the purpose of the 
screening level dietary risk assessment to support this request for an 
exemption from the requirement of a tolerance for 
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate], a conservative drinking water concentration value of 100 
ppb based on screening level modeling was used to assess the 
contribution to drinking water for the chronic dietary risk assessments 
for parent compound. These values were directly entered into the 
dietary exposure model.
    3. From non-dietary exposure. The term ``residential exposure'' is 
used in this document to refer to non-occupational, non-dietary 
exposure (e.g., for lawn and garden pest control, indoor pest control, 
termiticides, and flea and tick control on pets). 
Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-
tolyl)propionate] is registered for use as an inert ingredient in 
pesticide products that are registered for specific uses that may 
result in residential exposure, specifically lawn, turf, and garden 
use, and in indoor cleaning products. A conservative residential 
exposure and risk assessment was completed for pesticide products 
containing ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-
tolyl) propionate] as inert ingredients. The Agency assessed 
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate] in pesticide formulations (outdoor scenarios) and in 
disinfectant-type uses (indoor scenarios) at no more than 1% in the 
final formulation. The Agency's assessment of adult residential 
exposure combines high end dermal and inhalation handler exposure from 
indoor hard surface, aerosol spray with a high-end post application 
dermal exposure from contact with treated lawns. The Agency's 
assessment of children's residential exposure includes total post-
application exposures associated with contact with treated surfaces 
(dermal and hand-to-mouth exposures).

[[Page 8445]]

    4. Cumulative effects from substances with a common mechanism of 
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when 
considering whether to establish, modify, or revoke a tolerance, the 
Agency consider ``available information'' concerning the cumulative 
effects of a particular pesticide's residues and ``other substances 
that have a common mechanism of toxicity.''
    EPA has not found ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-
hydroxy-m-tolyl) propionate] to share a common mechanism of toxicity 
with any other substances, and ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate] does not appear to produce a toxic 
metabolite produced by other substances. For the purposes of this 
tolerance action, therefore, EPA has assumed that 
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate] does not have a common mechanism of toxicity with other 
substances. For information regarding EPA's efforts to determine which 
chemicals have a common mechanism of toxicity and to evaluate the 
cumulative effects of such chemicals, see EPA's website at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an 
additional tenfold (10X) margin of safety for infants and children in 
the case of threshold effects to account for prenatal and postnatal 
toxicity and the completeness of the database on toxicity and exposure 
unless EPA determines based on reliable data that a different margin of 
safety will be safe for infants and children. This additional margin of 
safety is commonly referred to as the FQPA SF. In applying this 
provision, EPA either retains the default value of 10X, or uses a 
different additional safety factor when reliable data available to EPA 
support the choice of a different factor.
    The Agency has concluded that there is reliable data to determine 
that infants and children will be safe if the FQPA SF of 10X is reduced 
to 1X for all exposure scenarios for the following reasons. The 
toxicity database for ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-
hydroxy-m-tolyl) propionate] contains subchronic, developmental, 
reproduction, chronic/carcinogenicity, and mutagenicity studies. There 
is no indication of immunotoxicity or neurotoxicity in the available 
studies; therefore, there is no need to require an immunotoxicity or 
neurotoxicity study. Fetal susceptibility is not observed in 
developmental toxicity studies in the rat. Developmental toxicity 
(reduced fetal body weight and delayed skeletal maturation) occurred at 
a higher dose, 300 mg/kg/day, than maternal toxicity (reduced body 
weight gain), which occurred at 100 mg/kg/day. Qualitative fetal 
susceptibility toxicity is observed 2-generation reproduction toxicity 
study. Pup mortality and reduced pup body weight is observed at 900 ppm 
(~54-62 mg/kg/day), while parental toxicity is manifested as decreased 
bodyweight gain and food consumption at the same dose. However, the 
established cRfD of 0.15 mg/kg/day will be protective of any offspring 
effects seen at 900 ppm (~54-62 mg/kg/day). Therefore, there is no 
concern for fetal susceptibility. Reproduction toxicity is not observed 
up to 1,800 ppm (87-221 mg/kg/day), the highest dose tested. Based on 
the adequacy of the toxicity database, the conservative nature of the 
exposure assessment, and the lack of concern for prenatal and postnatal 
sensitivity, the Agency has concluded that there is reliable data to 
determine that infants and children will be safe if the FQPA SF of 10X 
is reduced to 1X.

E. Aggregate Risks and Determination of Safety

    EPA determines whether acute and chronic dietary pesticide 
exposures are safe by comparing aggregate exposure estimates to the 
acute PAD (aPAD) and chronic PAD (cPAD). For linear cancer risks, EPA 
calculates the lifetime probability of acquiring cancer given the 
estimated aggregate exposure. Short-, intermediate-, and chronic-term 
risks are evaluated by comparing the estimated aggregate food, water, 
and residential exposure to the appropriate PODs to ensure that an 
adequate MOE exists.
    1. Acute risk. An acute aggregate risk assessment takes into 
account acute exposure estimates from dietary consumption of food and 
drinking water. No adverse effect resulting from a single oral exposure 
was identified and no acute dietary endpoint was selected. Therefore, 
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate] is not expected to pose an acute risk.
    2. Chronic risk. Using the exposure assumptions described in this 
unit for chronic exposure, EPA has concluded that chronic exposure to 
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate] from food and water will utilize 18.4% of the cPAD for 
children 1 to 2 years old, the population group receiving the greatest 
exposure.
    3. Short-term risk. Short-term aggregate exposure takes into 
account short-term residential exposure plus chronic exposure to food 
and water (considered to be a background exposure level).
    Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate] is currently used as an inert ingredient in pesticide 
products that are registered for uses that could result in short-term 
residential exposure, and the Agency has determined that it is 
appropriate to aggregate chronic exposure through food and water with 
short-term residential exposures to ethylenebis(oxyethylene) bis[3-(5-
tert-butyl-4-hydroxy-m-tolyl) propionate].
    Using the exposure assumptions described in this unit for short-
term exposures, EPA has concluded the combined short-term food, water, 
and residential exposures result in aggregate MOEs of 1,235 for adult 
males and females. Adult residential exposure combines high-end dermal 
and inhalation handler exposure from indoor hard surface, aerosol spray 
with a high-end post-application dermal exposure from contact with 
treated lawns. The combined short-term aggregated food, water, and 
residential pesticide exposures result in an aggregate MOE of 511 for 
children. Children's residential exposure includes total exposures 
associated with contact with treated surfaces (dermal and hand-to-mouth 
exposures). Because EPA's level of concern for ethylenebis(oxyethylene) 
bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] is a MOE of 100 or 
below, these MOEs are not of concern.
    4. Intermediate-term risk. Intermediate-term aggregate exposure 
takes into account intermediate-term residential exposure plus chronic 
exposure to food and water (considered to be a background exposure 
level).
    Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate] is currently used as an inert ingredient in pesticide 
products that are registered for uses that could result in 
intermediate-term residential exposure, and the Agency has determined 
that it is appropriate to aggregate chronic exposure through food and 
water with intermediate-term residential exposures to 
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate].
    Using the exposure assumptions described in this unit for 
intermediate-term exposures, EPA has concluded that the combined 
intermediate-term food, water, and residential exposures result in 
aggregate MOEs of 1,729 for adult males and females. Adult residential 
exposure includes high-end post-

[[Page 8446]]

application dermal exposure from contact with treated lawns. The 
combined intermediate-term aggregated food, water, and residential 
exposures result in an aggregate MOE of 413 for children. Children's 
residential exposure includes total exposures associated with contact 
with treated surfaces (dermal and hand-to-mouth exposures). Because 
EPA's level of concern for ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate] is a MOE of 100 or below, these 
MOEs are not of concern.]
    5. Aggregate cancer risk for U.S. population. In a chronic/
carcinogenicity study, thyroid gland tumors are observed at 100 mg/kg/
day in rats. However, based on the postulated mode of action for these 
tumors, they are not considered relevant to humans. Also, 
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate] is not mutagenic. Therefore, ethylenebis(oxyethylene) 
bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) propionate] is not expected to 
pose a cancer risk to humans.
    6. Determination of safety. Based on these risk assessments, EPA 
concludes that there is a reasonable certainty that no harm will result 
to the general population, or to infants and children from aggregate 
exposure to ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-
tolyl) propionate] residues.

V. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since 
the Agency is not establishing a numerical tolerance for residues of 
ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate] in or on any food commodities. EPA is establishing 
limitations on the amount of ethylenebis(oxyethylene) bis[3-(5-tert-
butyl-4-hydroxy-m-tolyl) propionate] that may be used in pesticide 
formulations applied to growing crops and raw agricultural commodities 
after harvest. These limitations will be enforced through the pesticide 
registration process under the Federal Insecticide, Fungicide, and 
Rodenticide Act (``FIFRA''), 7 U.S.C. 136 et seq. EPA will not register 
any pesticide formulation for use on growing crops and raw agricultural 
commodities after harvest for sale or distribution that exceeds 1% by 
weight of ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-
tolyl) propionate] unless additional data are submitted.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is 
established under 40 CFR 180.910 for ethylenebis(oxyethylene) bis[3-(5-
tert-butyl-4-hydroxy-m-tolyl) propionate] (CAS Reg No. 36443-68-2) when 
used as an inert ingredient (stabilizer), limited to 1% (by weight) in 
pesticide formulations applied to growing crops and raw agricultural 
commodities after harvest.

VII. Statutory and Executive Order Reviews

    This action establishes an exemption from the requirement of a 
tolerance under FFDCA section 408(d) in response to a petition 
submitted to the Agency. The Office of Management and Budget (OMB) has 
exempted these types of actions from review under Executive Order 
12866, entitled ``Regulatory Planning and Review'' (58 FR 51735, 
October 4, 1993). Because this action has been exempted from review 
under Executive Order 12866, this action is not subject to Executive 
Order 13211, entitled ``Actions Concerning Regulations That 
Significantly Affect Energy Supply, Distribution, or Use'' (66 FR 
28355, May 22, 2001) or Executive Order 13045, entitled ``Protection of 
Children from Environmental Health Risks and Safety Risks'' (62 FR 
19885, April 23, 1997), nor is it considered a regulatory action under 
Executive Order 13771, entitled ``Reducing Regulations and Controlling 
Regulatory Costs'' (82 FR 9339, February 3, 2017). This action does not 
contain any information collections subject to OMB approval under the 
Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it 
require any special considerations under Executive Order 12898, 
entitled ``Federal Actions to Address Environmental Justice in Minority 
Populations and Low-Income Populations'' (59 FR 7629, February 16, 
1994).
    Since tolerances and exemptions that are established on the basis 
of a petition under FFDCA section 408(d), such as the exemption in this 
final rule, do not require the issuance of a proposed rule, the 
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et 
seq.), do not apply.
    This action directly regulates growers, food processors, food 
handlers, and food retailers, not States or tribes, nor does this 
action alter the relationships or distribution of power and 
responsibilities established by Congress in the preemption provisions 
of FFDCA section 408(n)(4). As such, the Agency has determined that 
this action will not have a substantial direct effect on States or 
tribal governments, on the relationship between the National Government 
and the States or tribal governments, or on the distribution of power 
and responsibilities among the various levels of government or between 
the Federal Government and Indian tribes. Thus, the Agency has 
determined that Executive Order 13132, entitled ``Federalism'' (64 FR 
43255, August 10, 1999) and Executive Order 13175, entitled 
``Consultation and Coordination with Indian Tribal Governments'' (65 FR 
67249, November 9, 2000) do not apply to this action. In addition, this 
action does not impose any enforceable duty or contain any unfunded 
mandate as described under Title II of the Unfunded Mandates Reform Act 
(UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would 
require Agency consideration of voluntary consensus standards pursuant 
to section 12(d) of the National Technology Transfer and Advancement 
Act (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.), 
EPA will submit a report containing this rule and other required 
information to the U.S. Senate, the U.S. House of Representatives, and 
the Comptroller General of the United States prior to publication of 
the rule in the Federal Register. This action is not a ``major rule'' 
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure, 
Agricultural commodities, Pesticides and pests, Reporting and 
recordkeeping requirements.

    Dated: January 17, 2020.
Donna Davis,
Acting Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

     Authority: 21 U.S.C. 321(q), 346a and 371.


0
 2. In Sec.  180.910, add alphabetically the inert ingredient 
``Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl) 
propionate] (CAS Reg. No. 36443-68-2)'' to the table to read as 
follows:


Sec.  180.910  Inert ingredients used pre- and post-harvest; exemptions 
from the requirement of a tolerance.

* * * * *

[[Page 8447]]



                                               Table 1 to 180.910
----------------------------------------------------------------------------------------------------------------
            Inert ingredients                           Limits                               Uses
----------------------------------------------------------------------------------------------------------------
 
                                                  * * * * * * *
Ethylenebis(oxyethylene) bis[3-(5-tert-   1% by weight......................  Stabilizer.
 butyl-4-hydroxy-m-tolyl) propionate]
 (CAS Reg. No. 36443-68-2).
 
                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2020-02043 Filed 2-13-20; 8:45 am]
 BILLING CODE 6560-50-P


